Severe SepsisIMPRESSNCT01943747
International Multicentre Prevalence Study on Sepsis
An observational study of Severe Sepsis and Septic Shock, run by European Society of Intensive Care Medicine at 1 site in Belgium.
Trial summary
To mark 10 years of the Surviving Sepsis Campaign (SSC), and timed to coincide with World Sepsis Day, on September 13, 2013, the SSC, ESICM and SCCM will be conducting an international point prevalence study of severe sepsis and septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis, Septic Shock
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2013to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients presenting with either severe sepsis or septic shock
Who may be able to join
- To be eligible patients must have all of the following:
- Must be admitted or transferred to either the ED or an Intensive Care Unit.
- Have a high clinical suspicion of an infection
- Have sepsis as defined by an infection together with two or more SIRS criteria
- Evidence of acute organ dysfunction and/or Shock.
Who cannot join
- Patients less than 18 years of age
- Patients in whom the sepsis has been present from before the beginning of the study period
- Any patients previously included in the study during the same study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surviving Sepsis Campaign. International Multicentre Prevalence Study on Sepsis.
To mark 10 years of the Surviving Sepsis Campaign (SSC), and timed to coincide with World Sepsis Day, on September 13, 2013, the SSC, ESICM and SCCM will be conducting an international point prevalence study of severe sepsis and septic shock. The goal of this project is to determine the world wide burden of severe sepsis and define current practices of sepsis care internationally. The study is a simple data collection exercise for patients presenting with either severe sepsis or septic shock on World Sepsis Day.
Read the detailed description
De---identified patient---level data will be collected on patients presenting to a participating intensive care unit or emergency department with severe sepsis or septic shock over a 24 hour period from 00:00 to 24:00 November 07, 2013. De---identified data that is already collected as part of routine clinical care will be collected for this study. Data to be collected includes hospital and ICU characteristics, patient characteristics, severity of illness, and adherence to SSC bundle elements and mortality. It will take between 30---60 minutes to collect and enter data for each patient admitted with severe sepsis or septic shock over the 24 hours study period.
- Conditions
- Severe Sepsis, Septic Shock
- Keywords
- sepsis, severe sepsis, septic shock, infection, organ dysfunction, quality improvement
- Medical subject headings
- Sepsis, Shock, Septic, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
28-Day Mortality
Measured: one week
Secondary outcomes (1)
Organ Failure
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Society of Intensive Care Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Critical Care Medicine
- Responsible party
- Sponsor
- Investigators
- Andrew RHODES, MD, PhD, Principal investigator, European Society of Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943747
- Sponsor's protocol ID
- IMPRESS
- Acronym
- IMPRESS
- Status last verified
- Aug 2014
- First submitted
- 12 Sep 2013
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surviving Sepsis Campaign. International Multicentre Prevalence Study on Sepsis.
- ClinicalTrials.gov ID
- NCT01943747
- Acronym / sponsor ID
- IMPRESS / IMPRESS
- Conditions
- Severe Sepsis, Septic Shock
- Keywords
- sepsis, severe sepsis, septic shock, infection, organ dysfunction, quality improvement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- European Society of Intensive Care MedicineUniversity, hospital or other
- Collaborators
- Society of Critical Care Medicine
- Study start
- Nov 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To mark 10 years of the Surviving Sepsis Campaign (SSC), and timed to coincide with World Sepsis Day, on September 13, 2013, the SSC, ESICM and SCCM will be conducting an international point prevalence study of severe sepsis and septic shock. The goal of this project is to determine the world wide burden of severe sepsis and define current practices of sepsis care internationally. The study is a simple data collection exercise for patients presenting with either severe sepsis or septic shock on World Sepsis Day.
Detailed description
De---identified patient---level data will be collected on patients presenting to a participating intensive care unit or emergency department with severe sepsis or septic shock over a 24 hour period from 00:00 to 24:00 November 07, 2013. De---identified data that is already collected as part of routine clinical care will be collected for this study. Data to be collected includes hospital and ICU characteristics, patient characteristics, severity of illness, and adherence to SSC bundle elements and mortality. It will take between 30---60 minutes to collect and enter data for each patient admitted with severe sepsis or septic shock over the 24 hours study period.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients presenting with either severe sepsis or septic shock
Key inclusion criteria (5 listed)
- Must be admitted or transferred to either the ED or an Intensive Care Unit.
- Have a high clinical suspicion of an infection
- Have sepsis as defined by an infection together with two or more SIRS criteria
- Evidence of acute organ dysfunction and/or Shock.
Key exclusion criteria (3 listed)
- Patients less than 18 years of age
- Patients in whom the sepsis has been present from before the beginning of the study period
- Any patients previously included in the study during the same study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
28-Day Mortality
Time frame: one week
1 secondary outcome
Organ Failure
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew RHODES, MD, PhD principal investigator
European Society of Intensive Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis and Septic Shock, run by European Society of Intensive Care Medicine at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-Day Mortality (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2014.